The Heart Failure Diuresis Efficacy Comparison (DEA-HF) Study

NCT05904808 | Completed Phase 4 DMC

• 1 other identifier: 0067-23-RMB
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome.

Conditions

Chronic Heart Failure; Diuretics Drug Reactions; Congestive Heart Failure

Outcome Measures

Primary Outcomes (3)

• Sodium weight

  Na Weight (Spot Na \* total volume of urine)

  1st week visit (time zero)

• Sodium weight

  Na Weight (Spot Na \* total volume of urine)

  1 week after 1st visit

• Sodium weight

  Na Weight (Spot Na \* total volume of urine)

  2 weeks after 1st visit

Secondary Outcomes (18)

• Urine Volume

  1st week visit (time zero)

• Urine Volume

  1 week after 1st visit

• Urine Volume

  2 weeks after 1st visit

• Rate of symptomatic hypotension events

  A week after 1st visit

• Rate of symptomatic hypotension events

  2 weeks after 1st visit

Other Outcomes (15)

• Change in plasma volume

  A week after 1st visit

• Change in plasma volume

  2 weeks after 1st visit

• Change in plasma volume

  3 weeks after 1st visit

Study Arms (1)

Diuretic comparison

ACTIVE COMPARATOR

each participant will be followed for 4 consecutive weeks. during which 3 different diuretic regimens will be given (random sequence). Last week follow up without protocol regimen.

Drug: IV Furosemide; Drug: IV Furosemide and PO Metolazone; Drug: IV Furosemide and IV Acetazolamide

Interventions

IV Furosemide DRUG

Given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus

Diuretic comparison

IV Furosemide and PO Metolazone DRUG

Given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus +5mg PO Metolazone

Diuretic comparison

IV Furosemide and IV Acetazolamide DRUG

Furosemide would be given over 4-hour drip using IV pump, 40mg of the 250mg will be given as a bolus. 500mg IV Acetazolamide would be given in 100cc of saline over half an hour

Also known as: Oral Magnesium citrate 600mg

Diuretic comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent must be obtained before any study assessment is performed.
• Male or female patients 18 years of age or older
• Confirmed Diagnosis of Heart Failure (per ESC guidelines 20212)
• At least one sign of active congestion at recruitment: Jugular venous pressure(JVP)/Ascites/Edema/Pulmonary rales/Pleural effusion/ Lung ultrasound B lines \>3 lines (at 6 sites).

You may not qualify if:

• History of myocardial infraction in the last 14 days prior to patient randomization.
• History of a cardiac transplantation and/or ventricular assist device.
• Mean blood pressure \<60 mmHg at screening
• Simultaneous use of intravenous inotropes, vasopressors or nitroprusside due to acute decompensated heart failure in the last 14 days.
• Estimated glomerular filtration rate \<20ml/min/1.73m2 at screening
• Any circumstances where urine collection is not possible.
• Use of renal replacement therapy or ultrafiltration 30 days prior to patient randomization.
• Subjects who are pregnant or breastfeeding

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam MC

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide; Acetazolamide; magnesium citrate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Thiadiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aharon Abbo, MD

  Rambam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Cardio Vascular Research and Innovation Unit

Model Details: Single-site, single-arm, open-label, cross-over controlled study Randomization will determine the sequence of the three (3) regimens

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 15, 2023
• Study Start: April 19, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 24, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)